Treats the symptoms of cold and flu, such as cough, sore throat, fever, runny or stuffy nose, and body aches.

Brand Name(s):

666 Cold Preparation, Day Time, Daytime Cold & Flu Relief, Daytime Cold/Flu Formula, Daytime Flu + Severe Cold & Cough, Daytime Severe Cold & Cough Relief, Daytime/Nighttime Cold & Flu Relief, Foster&Thrive Daytime Cold & Flu Relief, Good Neighbor Pharmacy Day Time Cold & Flu, Good Sense Day Time Cold & Flu, Good Sense Daytime Flu & Severe Cold, Good Sense Daytime Flu & Severe Cold & Cough, Good Sense Flu Relief Therapy, Leader Cold Multi-Symptom, Leader Pain Relief Cold PE

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid, Packet, Tablet, Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed. It is not safe to take more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).
• Follow the instructions on the medicine label if you are using this medicine without a prescription.
• Do not take more than 4 doses of this medicine (8 tablespoons) in one day.
• Measure this medicine with the medicine cup provided in the package, or with a marked measuring spoon or oral syringe.

If a dose is missed:

• Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not drink alcohol while you are using this medicine. Acetaminophen can damage your liver and drinking alcohol can increase this risk. If you regularly drink 3 or more alcoholic drinks every day, do not take acetaminophen without asking your doctor.
• Do not also use other medicines that contain acetaminophen, or you may be getting more than a safe amount of this medicine. Many combination medicines contain acetaminophen, including products with brand names such as Alka-Seltzer Plus®, Comtrex®, Drixoral®, Excedrin Migraine®, Midol®, Sinutab®, Sudafed®, Theraflu®, and Vanquish®. Carefully check the labels of all other medicines you are using to be sure they do not also contain acetaminophen.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breast feeding. Tell your doctor if you have heart disease, liver disease, diabetes, thyroid problems, glaucoma, high blood pressure, or an enlarged prostate. Your doctor should know if you smoke or have asthma, emphysema, bronchitis, or a chronic cough.
• Do not give this medicine to a child under 12 years old unless your doctor tells you to.
• Call your doctor if your symptoms do not improve or if they get worse.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark-colored urine or pale stools.
• Fever that lasts longer than 3 days.
• Lightheadedness, fainting, weakness, sweating.
• Nausea, vomiting, loss of appetite, pain in your upper stomach.
• Ongoing cough with headache and skin rash.
• Redness, swelling, or any new symptoms.
• Unusual bleeding or bruising.
• Vomiting blood or material that looks like coffee grounds.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Nervousness, dizziness, or drowsiness.
• Trouble sleeping.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088